SUMMARY: The Food and Drug Administration (FDA) is announcing theavailability of summaries of medical and clinical pharmacology reviewsof pediatric studies submitted in supplements for Ciloxan(ciprofloxacin ophthalmic), Brevibloc (esmolol), Flovent (fluticasone),Fludara (fludarabine), Fosamax (alendronate), Lotensin (benazepril),Malarone (atovaquone and proguanil), Xenical (orlistat), and Ocuflox(ofloxacin ophthalmic). The summaries are being made availableconsistent with section 9 of the Best Pharmaceuticals for Children Act(BPCA). For all pediatric supplements submitted under the BPCA, theBPCA requires FDA to make available to the public a summary of themedical and clinical pharmacology reviews of the pediatric studiesconducted for the supplement.

ADDRESSES: The summaries are available for public examination between 9a.m. and 4 p.m., Monday through Friday, in the Division of DocketsManagement (HFA-305), Food and Drug Administration, 5630 Fishers Lane,rm. 1061, Rockville, MD 20852. Submit written requests for singlecopies of the summaries to the Division of Drug Information (HFD-240),Center for Drug Evaluation and Research, Food and Drug Administration,5600 Fishers Lane, Rockville, MD 20857. Please specify by product namewhich summary or summaries you are requesting. Send one self-addressedadhesive label to assist that office in processing your requests. Seethe SUPPLEMENTARY INFORMATION section for electronic access to thesummaries.

FDA is announcing the availability of summaries of medical andclinical pharmacology reviews of pediatric studies conducted forCiloxan (ciprofloxacin ophthalmic), Brevibloc (esmolol), Flovent(fluticasone), Fludara (fludarabine), Fosamax (alendronate), Lotensin(benazepril), Malarone (atovaquone and proguanil), Xenical (orlistat),and Ocuflox (ofloxacin ophthalmic). The summaries are being madeavailable consistent with section 9 of the BPCA (Public Law 107-109).Enacted on January 4, 2002, the BPCA reauthorizes, with certainimportant changes, the pediatric exclusivity program described insection 505A of the Federal Food, Drug, and Cosmetic Act (the act) (21U.S.C. 355a). Section 505A of the act permits certain applications toobtain 6 months of marketing exclusivity if, in accordance with therequirements of the statute, the sponsor submits requested informationrelating to the use of the drug in the pediatric population.One of the provisions the BPCA added to the pediatric exclusivityprogram pertains to the dissemination of pediatric information.Specifically, for all pediatric supplements submitted under the BPCA,the BPCA requires FDA to make available to the public a summary of themedical and clinical pharmacology reviews of pediatric studiesconducted for the supplement (21 U.S.C. 355a(m)(1)). The summaries areto be made available not later than 180 days after the report on thepediatric study is submitted to FDA (21 U.S.C. 355a(m)(1)). Consistentwith this

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provision of the BPCA, FDA has posted on the Internet (http://www.fda.gov/cder/pediatric/index.htm) summaries of medical and clinical